Inhaler Comprising A Base Having A Plurality of Medicament Containing Sealed Cavities

ABSTRACT

An inhaler which comprises a base having a plurality of consecutive sealed cavities containing medicament. Foil portions are on one side attached to the base for sealing the medicament within respective associated cavities. A plurality of separating elements are attached to the other side of the foil portions, each separating element being associated with a respective cavity for separating a foil portion from that cavity. Each separating element can be moved-away from its associated cavity so that the sealing foil portion is separated from the cavity which is thereby uncovered so that medicament contained therein is enabled to become entrained in a fluid flow, and then returned with the attached foil portion to cover its associated cavity. A method of operating an inhaler is also disclosed.

TECHNICAL FIELD

The present invention relates to an inhaler comprising a base having atleast one cavity containing medicament, such as in the form of drypowder medicament. The present invention also relates to a method inconnection with such an inhaler.

BACKGROUND OF THE INVENTION

There are different types of inhalers on the market. A pressurizedMetered Dose Inhaler (pMDI) releases a fixed dose of substance inaerosol form. A powder inhaler generally releases a dose of powderedsubstance entrained in an air stream. In a powder inhaler the powder maybe provided in a bulk container of the inhaler from which doses ofpowder are metered for dispensing. As an alternative to a bulkcontainer, powder inhalers may comprise a single compartment or aplurality of compartments for containing discrete doses of powderedsubstance. Such compartments may take the form of sealed blisters in ablister pack, a cavities-containing strip joined to a sealing strip orother suitable forms.

There are different solutions to opening compartments containingdiscrete doses of powder. WO 01/72605 discloses different embodiments ofa dose strip for use with a powder inhaler. Various opening mechanismsare disclosed. For instance, in FIG. 4 a lid strip covers spaced apartblisters. Lid tabs are attached to the lid strip over each blister. Apeel strip is joined to each lid tab. Pulling of the peel strip opensthe blisters. In FIG. 22 of WO 01/72605 a dose strip comprises a numberof blisters containing pharmaceutical powder. Each blister is connectedto a respective plunger. A blister is opened by a slider having a wedgethat engages a slot on the plunger. The wedge pulls the plunger down,breaking the seal and releasing pharmaceutical powder into a flow path,for inhalation.

SUMMARY OF THE INVENTION

An object of the present invention is to provide an alternative mannerof handling sealed compartments or cavities and elements associatedthereto inside an inhaler.

This and other objects, which will become apparent in the followingdisclosure, are accomplished by the invention defined in the accompaniedclaims.

The present invention is based on the insight that an opening elementmay be provided with dual functionality. Thus, after or before it hasbeen used for opening a sealed compartment containing powder, it mayhave another function different from the opening function. In particularit has been realised that an opening element may be in the form of aflow path-defining element for guiding a fluid flow. It has also beenrealised that an opening element may subsequently function as a closingelement for preventing possible powder remains to exit from a usedcompartment.

According to at least a first aspect of the invention, an inhaler isprovided. The inhaler comprises

a base having a plurality of medicament-containing sealed cavities whichare consecutively movable to a dispensing position of the inhaler,

foil portions which on one side are attached to the base for sealing themedicament within respective associated cavities and which on anopposite side are attached to a plurality of separating elements, eachseparating element being associated with a respective cavity forseparating a foil portion from that cavity,

an actuator adapted to provide an impact on the separating elementassociated with the cavity currently located in the dispensing position,thereby moving that separating element to a removed position in whichthe separating element is moved-away from the cavity so that the sealingfoil portion is separated from the cavity which is thereby uncovered sothat medicament contained therein is enabled to become entrained in afluid flow,

wherein, in the removed position of the separating element, the attachedfoil portion at least partly defines a flow path for the medicamententrained from the cavity.

Thus, the separating element is not just discarded when it has been usedto open the sealed cavity. Rather it now functions as a flowpath-defining element together with the attached foil portion.

According to at least one example embodiment, the separating elementcomprises a returned position in which the separating element with theattached foil portion is moved back to cover its associated cavity.Thus, the separating element is not just discarded after it has causedthe foil to separate from the cavity, but may be returned to cover thatcavity after a fluid flow has entrained powder therefrom. This will makeit difficult for any remaining powder to exit the covered used cavity,thus reducing the risk of dose variation which could occur if suchremaining powder would be entrained in a following inhalation. It alsoreduces the risk of remaining powder exiting the cavity and jammingmechanical components in the inhaler or creating a rattling noise whichwould be undesirable for the user.

Although the inhaler may suitably be a single dose inhalation device,the present inventive ideas may also be implemented in a multiple doseinhalation device. Thus, according to at least one example embodiment,the base has a plurality of consecutive sealed cavities containingmedicament, each cavity being sealed by a respective associated foilportion, wherein each foil portion is on its other side attached to aseparating element associated with a respective cavity for separating afoil portion from that cavity.

For explanatory purposes only, in the following description, it isassumed that the inhaler is oriented in such way that the cavities arelocated below the foil portions and that the separating elements arelocated above the foil portions. Thus, any directional or orientationalexpressions such as “upper”, “lateral”, “above”, “below” are used hereinwith said orientation of the inhaler in mind. However, it is to beunderstood that this definition is only used for creating a simplediscussion reference and thus the inhaler according to the invention isnot limited to a specific orientation. For simplicity and unnecessaryrepetition, the following discussion will mainly focus on a multipledose inhalation device. However, it is to be understood that at leastsome of the discussed features are applicable also to a single doseinhalation device.

According to at least an embodiment of the invention it is dislosed aninhaler comprising

a base having a plurality of medicament-containing sealed cavities whichare consecutively movable to a dispensing position of the inhaler,

foil portions which on one side are attached to the base for sealing themedicament within respective associated cavities and which on anopposite side are attached to a plurality of separating elements, eachseparating element being associated with a respective cavity forseparating a foil portion from that cavity,

an actuator adapted to provide an impact on the separating elementassociated with the cavity currently located in the dispensing position,thereby moving that separating element to a removed position in whichthe separating element is moved-away from the cavity so that the sealingfoil portion is separated from the cavity which is thereby uncovered sothat medicament contained therein is enabled to become entrained in afluid flow,

wherein the cavities are adapted to be indexed relative to the actuator.

For a multiple dose inhalation device, it has been realised that theseparating element may be used to define different flow paths related todifferent cavities. Accordingly, rather than obstructing the flow pathduring subsequent inhalations, the separating element may actually beused to, at least partly, define the different flow paths. Thus,according to at least one example embodiment, each separating elementcomprises a first wall portion to which the foil portion is attachedfor, at least partly, defining a flow path for its associated cavity anda second wall portion for, at least partly, defining the flow path for aneighbouring cavity. Thus, it should be understood that this exampleembodiment may be used in connection with an inhaler comprising aplurality of cavities having individual flow paths. Once the separatingelement has been removed from the base for allowing an inhalation totake place, it will not obstruct a subsequent inhalation, because thenext cavity has its own flow path. Thus, rather than becomingobstructing after its first use, it contributes in a second use indefining another flow path for another cavity.

Although said first and second wall portions of the separating elementmay be on one and the same side (e.g. due to possible rotation of theseparating element), said first and second wall portions are suitablylocated on different sides of the separating element. This is suitablefor creating individual flow paths for the cavities. Thus, by avoidingusing the same wall portion twice, the risk of powder remains that haveadhered to such a wall portion becoming entrained in a subsequentinhalation flow is considerably reduced. Typically, the first wallportion would face its associated cavity which is located below saidfirst wall portion, thereby being capable of forming an upper flowpath-defining wall portion to said associated cavity when lifted fromthe cavity. Typically, the second wall portion would be at leastsomewhat perpendicular to said first wall portion, thereby being capableof forming a lateral flow path-defining wall portion to the neighbouringcavity.

When the separating element is distanced from its associated cavity inorder to remove the foil and to uncover said cavity, the foil remainsattached to the separating element. Thus, the removed foil portionbecomes part of the first wall portion for defining the flow path.

The foil portions may be provided as one foil and, optionally, the foilportions may be defined by perforations or other material weakenings. Asan alternative to a single foil, the foil portions may be applied in theform of individual patches. The foil portions may be attached to thebase and the separating elements by welding, gluing or other suitablemethod. It should be noted that the terms “foil” and “foil portion” arenot limited to a single material layer. On the contrary a foil or foilportion may comprise a plurality of layers. For instance, foil maycomprise a metal layer which is coated with lacquer or polymer layer onone or both sides in any suitable combination in order to provide thedesired stiffness, attachment capability, etc.

According to at least one example embodiment of the invention, eachseparating element comprises a third wall portion for, at least partly,defining the flow path for another neighbouring cavity on the other sideof said associated cavity. Typically, that third wall portion would beat least somewhat perpendicular to said first wall portion, therebybeing capable of forming a lateral flow path-defining wall portion tosaid other neighbouring cavity.

As previously mentioned, although it is conceivable that the separatingelements may be moved in such way that a wall portion performs a flowpath-defining function for more than one cavity, it is appropriate thatfor each one of said wall portions, its flow path-defining function isperformed only in relation to one respective cavity. Thus, for instancethe first wall portion of a given separating element could partly definea flow path for powder in the cavity below the separating element, whilethe second and third wall portions could partly define flow paths forthe two neighbouring cavities located left and right, respectively, ofthe separating element.

As mentioned previously, the separating element may be moved away fromits associated cavity in order to separate a respective foil portionfrom said cavity and to create an upper flow path-defining wall portion.Separating elements which are located adjacent to said moved-awayseparating element may also form part in defining the flow path,typically as lateral flow path-defining wall portions. This is reflectedin at least one example embodiment of the invention, wherein said fluidflow is guided by a flow path which is at least partly defined by first,second and third consecutive separating elements, wherein only theintermediate second separating element is in said removed position. Inother words each separating element has a first position in which itcovers the opening of its associated cavity and a second position (abovereferred to as “removed position”) in which it is distanced from thecavity and allows a fluid flow to entrain medicament from the cavity.Thus, the first position is both the initial position (i.e. the state inwhich the foil is still attached before removal of the separatingelement) and the returned position mentioned above (i.e. after theseparating element has been removed for bringing along the foil portionand then returned).

it should be noted that the separating elements may return from thesecond (removed) position to the first (returned) position, in order tofunction as a lateral flow path-defining wall portion for a neighbouringcavity. To give an example, assume there are three consecutive cavities:a first cavity having an associated first separating element, a secondcavity having an associated second separating element and a third cavityhaving an associated third separating element. The second separatingelement could then initially function as a lateral flow path-definingwall portion for a fluid flow that entrains powder from the first cavity(when uncovered). Then, the second separating element can be moved awayfrom the associated second cavity in order to function as an upper flowpath-defining wall portion for a fluid flow that entrains powder fromthe thus uncovered second cavity. Finally, the second separating elementcan be moved back to the associated second cavity in order to functionas a lateral flow path-defining wall portion for a fluid flow thatentrains powder from the third cavity (when uncovered).

The above exemplified multiple functionality of the separating elementis at least partly reflected in at least one example embodiment of theinvention, wherein each separating element has a first (initial orreturned) position in which it covers the opening of its associatedcavity, and a second (removed) position in which it is distanced fromthe cavity, wherein each one of said separating elements is in saidsecond (removed) position adapted to at least partly define a flow pathfor a fluid flow to entrain medicament from the associated cavity, andin said first (initial or returned) position, together with aneighbouring separating element in said second position, adapted to atleast partly define a flow path for a fluid flow to entrain medicamentfrom the cavity associated with said neighbouring separating element.

Although, it has been described above that a separating element may, atleast partly, form a lateral flow path-defining wall portion for aneighbouring cavity, an alternative would be to provide fixed lateralflow path-defining elements. According to at least one exampleembodiment of the invention, a partition wall is provided between eachpair of neighbouring separating elements, and extends perpendicularlyupwards from the base. There would be two lateral partition wallsassisting in defining a flow path, one on each lateral side of thecavity (regarded in the fluid flow direction), while the separatingelement associated with that cavity would, when raised, form an upperflow path-defining wall portion. When assembled, the partition wallscould be mounted onto the foil that covers (or is intended to latercover) the cavities in such way that they cause a weakening in the foil,thereby establishing defined foil portions between the partition walls.

According to at least one example embodiment of the invention, eachseparating element comprises an actuator-receiving portion, wherein theinhaler comprises an actuator adapted to provide a force onto theactuator-receiving portion to cause the separating elements to move fromsaid first position to said second position. The opening force may comefrom below and push the actuator-receiving portion upwards.Alternatively, the opening force may be achieved by providing an upperpulling force onto the actuator-receiving portion. Thus, depending onthe direction of force and the actuator providing the force, theactuator-receiving portion may be designed in various ways, such asprotrusions, dogs, hooks, indentations, overhangs, channels, etc.

In order to separate a foil portion from the cavity it is sealing, thefoil portion should be appropriately attached to its associatedseparating element. According to at least one example embodiment of theinvention, the attachment force between the separating elements and therespective associated foil portions is larger than the attachment forcebetween the base and the foil portions, whereby movement of such aseparating element away from its associated cavity causes the associatedfoil portion to become separated from the base.

Suitably, the contact area between a foil portion and its associatedattached separating element is dimensioned in such way that no flowruptured obstructing foil parts will remain after the separation hasoccurred. In other words, the flow path downstream and upstream of thecavity opening should be free from any obstructing fringes of foil.Suitably, on the base, the flow path upstream and downstream of thecavity opening is completely foil free after the separation hasoccurred. This may be accomplished by designing the separating elementwith longer (or equal) extension in the flow path direction than that ofthe foil portion. Since the foil portion extends across the cavityopening in order to seal the cavity, the attached separating elementshould also extend at least across the cavity opening. As mentionedpreviously, the foil portions may form part of one covering foilprovided with perforations or weakenings which define the foil portions.Such perforations would be present between the cavity openings, and whenthe foil portions are ruptured at those perforations or weakenings anyfringes would be located laterally of the cavity viewed from a flowdirection perspective, and consequently no obstructing fringes would bepresent upstream or downstream of the cavity.

There are various way to obtain a larger attachment force at theseparating element/foil portion interface than at the foil portion/baseinterface. According to at least one example embodiment of theinvention, the contact surface between a separating element and itsassociated foil portion is larger than the contact surface between thatfoil portion and the base. In other words the separating element/foilportion interface is larger than the foil portion/base interface. If theseparating element covers the entire foil portion, then the contactsurface will automatically be larger between the separating element andthe foil portion than the contact surface between the foil portion andthe base, because the piece of the foil portion located directly abovethe cavity opening is not attached to anything and only the surroundingarea of the foil is attached to the base.

Another way to obtain different attachment forces is considered in atleast one other example embodiment of the invention. The foil portionsmay comprise a first coating layer to which the base is attached and asecond coating layer to which the separating elements are attached,wherein the tensile strength of the second coating layer is larger thanthe tensile strength of the first coating layer. The layers can providedifferent bonding properties, e.g. welds of different types of material,or glues of different types or amounts, or any combination thereof.

Other ways to obtain the difference in attachment forces could be toprovide the separating element with specially designed geometricfeatures, e.g. grooves into which the foil may be attached or otherfeatures that e.g. pierce the foil to create a firm grip.

Although the foil portion may be folded into grooves of the separatingelement or otherwise curved around the separating element e.g. toincrease the attachment area, the foil portion may suitably just beflat, i.e. only extending in a single plane parallel to the base. Thisenables a simple assembling of the separating elements to the foilportions. When they have become assembled the foil may be attached tothe base. An alternative would be to first attach the foil portions tothe base, and then attach the separating elements onto the respectivefoil portions.

Suitably, the stiffness of the separating elements is substantiallylarger than the stiffness of the foil portions, wherein the separatingelements enable the foil portions to perform a rigid body motion, andmay thus become snapped off the base rather than peeled off.

Although the above exemplified embodiments have discussed one cavityhaving one associated separating element, an alternative would be tohave two cavities having one common associated separating element. Forinstance, if two incompatible drug components are to be inhaledessentially simultaneously, they are suitably be provided in twoseparate cavities. The two cavities may be covered and sealed by onecommon foil portion (or one foil portion each), which in turn isattached to a common associated separating element extending across bothcavities. Thus, when the separating element is moved away from thecavity, it will bring along the foil portion, uncovering both cavitiesfrom which the drug components can be entrained in an inhalation flow.The cavities could either be located in series in the base, i.e. onecavity being downstream of the other one, or they could be located inparallel, i.e. the inhalation flow reaches the cavities essentiallysimultaneously.

Although an inhaler may be linear having the consecutive cavitiesaligned along a straight line, it may suitably be designed as agenerally annular, shape. In particular, according to at least oneexample embodiment of the invention, the base is shaped as a circulardisk and the cavities are provided consecutively in a circulararrangement or path around the disk. Thus, when medicament has beeninhaled from one cavity, the base is rotated relative to a mouthpiece ornasal adaptor of the inhaler in order to index the inhaler to the nextcavity.

According to at least a second aspect of the invention, there isprovided a method in an inhaler comprising a base having a plurality ofmedicament-containing cavities which may consecutively be moved to adispensing position of the inhaler, the inhaler being provided with foilportions which on one side are attached to the base for sealing themedicament within respective associated cavities and which on anopposite side are attached to a plurality of separating elements, eachseparating element being associated with a respective cavity forseparating a foil portion from that cavity. The method comprises:

moving a separating element away from its associated cavity so that thesealing foil portion becomes separated from the cavity which becomesuncovered,

entraining in a fluid flow medicament from the uncovered cavity whensaid uncovered cavity is in said dispensing position,

returning the moved separating element to cover its associated cavity,

indexing the base to move the next cavity to said dispensing position.

The separation of the foil portion from the cavity by moving away of theseparating element may, for instance, be performed before said indexing.Another alternative would be to perform the separation after saidindexing. The above method may be used in inhalers as discussed inconnection with the first aspect of the invention, i.e. the inhalershaving separating elements which act as flow path-defining elements bothfor respective associated cavities and for neighbouring cavities. Theabove method may, however, also be used in inhalers in which eachseparating element only act as a flow path-defining element for itsassociated cavity which it has covered. For instance, partition wallsmay be provided between the separating elements and extendperpendicularly upwards from the base. Such partition walls would formlateral flow path-defining wall portions, while a raised separatingelement would form the upper flow path-defining wall portion. Whenassembled, the partition walls could be mounted onto the foil covering(or intended to later cover) the cavities in such way that they cause aweakening in the foil, thereby establishing defined foil portionsbetween the partition walls.

According to at least one example embodiment of the invention, said actof moving comprises applying a force which pushes the separating elementaway from the cavity. An alternative is that said act of movingcomprises applying a force which pulls the separating element away fromthe cavity.

According to at least one example embodiment of the invention, themethod comprisies, after said moving away of the separating element,aligning it such that a side of the separating element facing the cavityopening becomes located in parallel with the cavity opening. Thus,referring to the terminology used when discussing the first aspect ofthe invention, the first wall portion would be aligned in parallel withand facing its associated cavity which is located below said first wallportion, thereby being capable of forming an upper flow path-definingwall portion to said associated cavity when lifted from the cavity, saidupper flow path-defining wall portion being parallel with the planedefined by the rim of the cavity opening. This allows of a fluid flowwhich may travel essentially in parallel with the plane defined by therim of the cavity opening, wherein such fluid flow does not per se enterthe cavity but instead creates an eddy or a vortex in the cavity whichcauses the medicament to leave the cavity and join the fluid flow.Depending on the desired flow path characteristics, there are otheralternatives to having such parallel alignment of the separating elementand the cavity opening. For instance, it would be conceivable to providethe facing side of the moved separating element at an inclination angle(other than a zero angle, which would be the parallel alignment) againstthe plane defined by the rim of the cavity opening. This allows of afluid flow to be directed at least partly into the cavity, or toincrease or decrease the flow velocity, or other possible effects.

It should be understood that the second aspect of the inventionencompasses any embodiments or any features described in connection withthe first aspect of the invention, as long as those embodiments orfeatures are compatible with the method of the second aspect.

The inhaler may contain various drugs and/or bioactive agents to beinhaled.

The bioactive agent may be selected from any therapeutic or diagnosticagent. For example it may be from the group of antiallergics,bronchodilators, bronchoconsitrictors, pulmonary lung surfactants,analgesics, antibiotics, leukotrine inhibitors or antagonists,anticholinergics, mast cell inhibitors, antihistamines,antiinflammatories, antineoplastics, anaesthetics, anti-tuberculars,imaging agents, cardiovascular agents, enzymes, steroids, geneticmaterial, viral vectors, antisense agents, proteins, peptides andcombinations thereof.

Examples of specific drugs which can be incorporated in the inhalationdevice according to the invention include mometasone, ipratropiumbromide, tiotropium and salts thereof, salemeterol, fluticasonepropionate, beclomethasone dipropionate, reproterol, clenbuterol,rofleponide and salts, nedocromil, sodium cromoglycate, flunisolide,budesonide, formoterol fumarate dihydrate, Symbicort™ (budesonide andformoterol), terbutaline, terbutaline sulphate, salbutamol base andsulphate, fenoterol,3-[2-(4-Hydroxy-2-oxo-3H-1,3-benzothiazol-7-yl)ethylamino]-N-[2-[2-(4-methylphenyl)ethoxy]ethyl]propanesulphonamide,hydrochloride. All of the above compounds can be in free base form or aspharmaceutically acceptable salts as known in the art.

Combinations of drugs may also be employed, for exampleformoterol/budesonide; formoterol/fluticasone; formoterol/mometasone;salmeterol/fluticasone; formoterol/tiotropium salts;zafirlukast/formoterol, zafirlukast/budesonide; montelukast/formoterol;montelukast/budesonide; loratadine/montelukast andloratadine/zafirlukast.

Further combinations include tiotropium and fluticasone, tiotropium andbudesonide, tiotropium and mometasone, mometasone and salmeterol,formoterol and rofleponide, salmeterol and budesonide, salmeterol androfleponide, and tiotropium and rofleponide.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of an inhaler according to at least oneexample embodiment of the invention, part of the inhaler housing beingcut-away to illustrate some internal details.

FIG. 2 illustrates schematically the assembling of separating elementsonto a base having a plurality of cavities.

FIGS. 3 a-3 e schematically illustrate an operating sequence whichincludes separating a foil portion from the cavity that it is coveringand dispensing the medicament contained in the cavity.

FIGS. 4 a-4 e schematically illustrate an alternative operating sequencewhich includes separating a foil portion from the cavity that it iscovering and dispensing the medicament contained in the cavity.

FIGS. 5 a-5 c schematically illustrate a sequence which substantiallycorresponds to the sequence illustrated in FIGS. 3 a-3 c, however viewedagainst the direction of the fluid flow.

FIG. 6 schematically illustrates an example embodiment as an alternativeto what is illustrated in FIG. 5 a.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of an inhaler 2, part of the inhaler housing4 being cut-away to illustrate some internal details. The housing 4encloses a base 6 having a plurality of cavities 8 sealed by a foil 10(see FIG. 2). For each cavity 8, there is attached a separating element12 on top of the foil. An actuator 14, herein illustrated as comprisingan arm, extends from a central location of the inhaler 2. The actuator14 is adapted to engage one separating element 12 at a time and to moveit upwardly in order to separate a foil portion from the cavity 8 belowthe separating element 12. Thereby, medicament contained in the cavity 8can be entrained in a fluid flow to be inhaled by a user. In thisexample, the fluid flow is in the form of an air-flow and the medicamentexits the inhaler 2 via a mouthpiece 16.

The actuator 14 may be manually operated by pushing, pressing, rotatingetc. a button, lever or the like on the inhaler housing 4 (not shown),or may be triggered by a user's inhalation in which case it would belatched by an air-flow sensitive release mechanism (not shown).

Before, during or after inhalation the base 6 is rotated (indexed) tobring the next cavity 8 into position. This may be implemented invarious ways, such as using a standard lever on the housing 4. Anotheralternative could be to use a connection between the base 6 and amouthpiece cover, wherein removal (or replacement) of the mouthpiececover would cause the base 6 to index one step to the next cavity 8. Yetanother alternative could be to use a breath-triggering mechanism tocause the base 6 to index one step.

The inhaler 2 may suitably comprise a structure that provides a moistureprotection, such as e.g. a moisture absorbent sink as described inWO2006/000758, or any other appropriate alternative for includingdesiccant material.

FIG. 2 illustrates schematically the assembling of separating elements12 onto a base 6 having a plurality of cavities 8. The base 6 has ageneral annular and circular shape, wherein the cavities 8 are arrangedin a circular path along the base. When the cavities have been providedwith powdered medicament, a foil 10 may be placed on the base 6 to sealthe cavities 8, and then a plurality of separating elements 12 areplaced on top of the foil 10 so as to mate and align each separatingelement 12 with a respective cavity 8. Alternatively, the plurality ofseparating elements 12 may first be attached to a foil and then saidfoil is attached to the base 6 to seal the cavities 8. Whicheveralternative is used, the foil 10 may be provided with perforations orweakenings to define foil portions that are readily separable from thecavities when the separating element is lifted from the base. Suchperforations or weakenings may e.g. be performed in a separateproduction step, but could alternatively be achieved when the foil isattached to the base and/or the separating elements if the base and/orthe separating elements have structural features which create theperforations or weakenings during the attachment step. The finishedassembly of base 6, foil 10 and separating elements 12 may then insertedinto the housing 4 or some other holding structure, e.g. as disclosed inWO2006/000758.

Most components of the inhaler 2, such as the base 6, the separatingelements 12 and the actuator 14 are suitably made of a plastic material,such as a polymer, however, other materials, such as metal or ceramicare conceivable alternatives.

FIGS. 3 a-3 e schematically illustrate an operating sequence whichincludes separating a foil portion 110 from the cavity 108 that it iscovering and dispensing the medicament contained in the cavity 108.

FIG. 3 a is a cross-sectional view of a cavity 108 in the base 106,wherein the cavity 108 contains powdered medicament 118 and is sealed bya foil portion 110. The foil portion 110 is attached by any suitabletype of bonding, welding, gluing etc, to an area of the base 106 whichsurrounds the rim of the cavity opening. A separating element 112 isattached by any suitable type of bonding, welding, gluing, etc. to thefoil portion 110. In the extension of the flow path direction, theseparating element 112 covers the entire foil portion 110, the flow pathdirection being illustrated by the arrows in FIG. 3 d. Thus, the contactarea between the separating element 112 and the foil portion 110 islarger than the contact area between the foil portion 110 and the base106, enabling the achievement of a larger attachment force between theseparating element 112 and the foil portion 110 compared to theattachment force between the foil portion 110 and the base 106.

The separating element 112 comprises a lower portion 122 and an upperportion 124, which may be produced in one piece or as two separatepieces joined together. There is a space 126 between the lower portion122 and the upper portion 124. The space 126 is formed like a bay whichopens towards the centre of the inhaler, i.e. towards the actuator 114.The upper portion 124 has an underside 128 that faces the space 126 andthe lower portion 122, said underside 124 being somewhat curved toenable the actuator 114 to tilt and align the separating element 112 aswill be explained in relation to FIGS. 3 b-3 c. In the positionillustrated in FIG. 3 a, the actuator 114 has been insertedsubstantially horizontally into the space 126.

As the end portion 130 of the actuator 114 is pivoted upwards to acertain inclination, it engages the underside 128 of the upper portion124 at a first point P1, affecting it with a lifting force, asillustrated in FIG. 3 b. This causes the separating element 112 togetherwith the attached seal or foil portion 110 to be raised in a pivotingmotion, around a pivot point 132 at the end of the foil/base interfacedownstream of the cavity 108.

The actuator 114, with maintained angle of inclination, then movesforward in the flow direction, i.e. further into the bay-shaped space126. This causes the foil portion 110 and the attached separatingelement 112 to completely separate from the base 106. Further into thebay-shaped space 126, the underside 128 is more cut out than at saidfirst point P1 of the underside 128. When the end portion 130 of theactuator 114 reaches an inner second point P2 of the underside 128, theseparating element 112 has been pivoted in the other direction, bringingthe separated foil portion 110 into a plane which is parallel with themain plane of the base 106, as illustrated in FIG. 3 c. This is due tothe curvature of the underside of the upper portion 124. The verticaldistance (vertical in this case being e.g. the direction from the base106 towards the separating element 112) between said first point P1 andsaid second point P2 is dimensioned to be equal to the vertical distancebetween those portions of the actuator 114 that contact said first andsecond points, respectively, when the actuator 114 is at a desired angleof inclination. It should be understood, that this is just an exampleembodiment, and that it would be conceivable to use another curvature ofthe underside in order to obtain another orientation of the separatingelement and the attached foil portion in relation to the base.

As illustrated in FIG. 3 d, when the foil portion 110 has beencompletely separated from the base 106 and the cavity 108 and reached adesired position, the fluid flow may entrain the powdered medicament 118from the cavity 108. The direction of the fluid flow is illustrated bythe arrows, upstream being towards the centre of the inhaler 2 withrespect to the cavity 108 and downstream being radially towards themouthpiece 16 (see FIG. 1). The fluid flow, may be initiated in responseto a user inhaling through the mouthpiece 16. Alternatively, it may beactuated by manually releasing a built-up pressure in a pressure chamberwhich is in communication with the flow path extending between theraised separating element 112 (including foil portion 110) and the base106.

After inhalation, the actuator 114 is removed and the separating element112 with the attached foil portion 110 becomes lowered onto the base 106to a returned position, which corresponds to its initial position, onceagain covering the cavity 108, as illustrated in FIG. 3 e.

Although, in FIGS. 3 a-3 e, the actuator 114 has been illustrated ascomprising an arm and the separating element 112 has been illustrated ascomprising a bay-shaped space 126 between an upper portion 124 and alower portion 122, other alternative embodiments are conceivable formoving the separating element 112 with the attached foil portion 110away from the base 106. The illustrated example embodiments are notlimiting in any way and are merely included for explanatory purposes.

FIGS. 4 a-4 e schematically illustrate an operating sequence whichincludes separating a foil portion 110 from the cavity 108 that it iscovering and dispensing the medicament contained in the cavity 108.

FIG. 4 a is a cross-sectional view of a cavity 108 in the base 106,wherein the cavity 108 contains powdered medicament and is sealed by afoil portion 110. The foil portion 110 is attached by any suitable typeof bonding, welding, gluing etc, to an area of the base 106 whichsurrounds the rim of the cavity opening. A separating element 112′ isattached by any suitable type of bonding, welding, gluing, etc. to thefoil portion 110. In the extension of the flow path direction, theseparating element 112′ covers the entire foil portion 110, the flowpath direction being illustrated by the arrows in FIG. 4 d. Thus, thecontact area between the separating element 112′ and the foil portion110 is larger than the contact area between the foil portion 110 and thebase 106, enabling the achievement of a larger attachment force betweenthe separating element 112′ and the foil portion 110 compared to theattachment force between the foil portion 110 and the base 106.

The separating element 112′ comprises a lower portion and an upperportion, which may be produced in one piece or as two separate piecesjoined together. There is an upper surface 140 of the separating element112′. The upper surface 140 describes a sloping path at the part whichis situated towards the centre of the inhaler, i.e. towards the actuator114′. The actuator 114′ is a claw adapted to fit around the edge of theseparating element 112′. When the claw is pivoted the movement makes itengage with the separating element 112′ and to tilt and align theseparating element 112 as will be explained in relation to FIGS. 4 b-4c. The actuator 114′ comprises an upper end portion 151 and a lower endportion 152.

As the end portion 152 of the actuator 114′ is pivoted upwards to acertain inclination, it engages the underside 128 of the separatingelement 112′ at a first point P1, affecting it with a lifting force, asillustrated in FIG. 4 b. This causes the separating element 112′together with the attached seal or foil portion 110 to be raised in apivoting motion, around a pivot point at the end of the foil/baseinterface downstream of the cavity 108.

The actuator 114′ then pivots further for engagement of the upper endportion 151 with the sloping path 140. This causes the foil portion 110and the attached separating element 112′ to completely separate from thebase 106. When the end portion 151 of the actuator 114′ reaches an innersecond point 92 of the underside 128, the separating element 112′ hasbeen pivoted in the other direction, bringing the separated foil portion110 into a plane which is parallel with the main plane of the base 106,as illustrated in FIG. 4 c. This is due to the curvature of the slopingportion of the upper portion 140. The vertical distance (vertical inthis case being e.g. the direction from the base 106 towards theseparating element 112) between said first point P1 and said secondpoint P2 is dimensioned to be equal to the vertical distance betweenthose portions of the actuator 114′ that contact said first and secondpoints, respectively, when the actuator 114′ is at a desired angle ofinclination. It should be understood, that this is just an exampleembodiment, and that it would be conceivable to use another curvature ofthe sloping portion in order to obtain another orientation of theseparating element and the attached foil portion in relation to thebase.

As illustrated in FIG. 4 d, when the foil portion 110 has beencompletely separated from the base 106 and the cavity 108 and reached adesired position, the fluid flow may entrain the powdered medicament 118from the cavity 108. The direction of the fluid flow is illustrated bythe arrows, upstream being towards the centre of the inhaler 2 withrespect to the cavity 108 and downstream being radially towards themouthpiece 16 (see FIG. 1). The fluid flow, may be initiated in responseto a user inhaling through the mouthpiece 16. Alternatively, it may beactuated by manually releasing a built-up pressure in a pressure chamberwhich is in communication with the flow path extending between theraised separating element 112′ (including foil portion 110) and the base106.

After inhalation, the actuator 114′ is removed and the separatingelement 112′ with the attached foil portion 110 becomes lowered onto thebase 106 to a returned position, which corresponds to its initialposition, once again covering the cavity 108, as illustrated in FIG. 4e.

Although, in FIGS. 4 a-4 e, the actuator 114′ has been illustrated ascomprising a claw and the separating element 112′ has been illustratedas comprising a sloping portion 140 at an upper portion positionedtowards the centre of the inhaler, other alternative embodiments areconceivable for moving the separating element 112′ with the attachedfoil portion 110 away from the base 106. The illustrated exampleembodiments are not limiting in any way and are merely included forexplanatory purposes.

FIGS. 5 a-5 c schematically illustrate a sequence which substantiallycorresponds to the sequence illustrated in FIGS. 3 a-3 c, however viewedagainst the direction of the fluid flow. For facilitating theunderstanding of the following discussion, there will be referred to afirst cavity 208 a, a second cavity 208 b and a third cavity 208 c. Theyare covered by respective first, second and third foil portions 210a-210 c and respective first, second and third separating elements 212a-212 c. Medicament powder in the first cavity 208 a has already beenentrained in a fluid flow after the associated separating element 212 ahas removed the covering foil portion 210 a from the cavity 208 a. Asillustrated in FIG. 5 a, the separating element 212 a with the attachedfoil portion 210 a has been returned to the base 206 to cover the firstcavity 208 a. The second cavity 208 b is still sealed by a foil portion210 b and is next to be presented for inhalation of medicament. Thethird cavity 208 c will be presented in position for inhalation afterthe medicament has been dispensed from the second cavity 208 b.

FIG. 5 b illustrates the upwards pivoting of the second separatingelement 212 b and attached foil portion 210 b which are covering thesecond cavity 208 b, thus corresponding to the action illustrated inFIG. 3 b.

FIG. 5 c illustrates the second cavity 208 b being completely uncoveredas the separating element 212 b has completely removed the foil portion210 b from the base 206 and the second cavity 208 b, thus correspondingto the position illustrated in FIG. 3 c. In this position, the powderedmedicament may become entrained in a fluid flow by-passing or enteringthe second cavity 208 b. The flow path is upwardly defined by the secondfoil portion 210 b attached to the second separating element 212 b, andis thus now considered as part of the second separating element 212 b.The underside of this separating element 212 b and the attached foilportion 210 b thus form a first flow path-defining wall portion. Thefirst separating element 212 a and the third separating element 212 chave a lateral flow path-defining wall portion 236 a, 236 c each for thesame flow path.

It should thus be noted, that different wall portions of a separatingelement will be used for defining flow paths for different cavities. Onewall portion is used for the associated cavity below the separatingelement, and other wall portions are used for neighbouring cavities.Thus, the second separating element 212 b also has a lateral second wallportion 236 b which has already been used for defining a flow path forentraining medicament from the first cavity 208 a. Furthermore, thesecond separating element 212 b has a lateral third wall portion 236 b′which will be used for defining a flow path when medicament is to beentrained from the third cavity 208 c.

FIG. 6 schematically illustrates an example embodiment as an alternativeto what is illustrated in FIG. 4 a. Partition walls 300 are providedbetween neighbouring separating elements 312. The partition walls 300extends perpendicularly upwards from the foil 310 on the base 306. Thus,when a separating element 312 is moved away from the base 306, therewill be two lateral partition walls 300 assisting in defining a flowpath, while the moved separating element 312 will form an upper flowpath-defining wall portion.

1. An inhaler, comprising a base having a plurality ofmedicament-containing sealed cavities which are consecutively movable toa dispensing position of the inhaler, foil portions which on one sideare attached to the base for sealing the medicament within respectiveassociated cavities and which on an opposite side are attached to aplurality of separating elements, each separating element beingassociated with a respective cavity for separating a foil portion fromthat cavity, and an actuator adapted to provide an impact on theseparating element associated with the cavity currently located in thedispensing position, thereby moving that separating element to a removedposition in which the separating element is moved-away from the cavityso that the sealing foil portion is separated from the cavity which isthereby uncovered so that medicament contained therein is enabled tobecome entrained in a fluid flow, wherein, in the removed position ofthe separating element, the attached foil portion at least partlydefines a flow path for the medicament entrained from the cavity andwherein a partition wall is provided between each pair of neighbouringseparating elements, and extends perpendicularly upwards from the base.2. An inhaler, comprising a base having a plurality ofmedicament-containing sealed cavities which are consecutively movable toa dispensing position of the inhaler, foil portions which on one sideare attached to the base for sealing the medicament within respectiveassociated cavities and which on an opposite side are attached to aplurality of separating elements, each separating element beingassociated with a respective cavity for separating a foil portion fromthat cavity, and an actuator adapted to provide an impact on theseparating element associated with the cavity currently located in thedispensing position, thereby moving that separating element to a removedposition in which the separating element is moved-away from the cavityso that the sealing foil portion is separated from the cavity which isthereby uncovered so that medicament contained therein is enabled tobecome entrained in a fluid flow, wherein the cavities are adapted to beindexed relative to the actuator and wherein a partition wall isprovided between each pair of neighbouring separating elements, andextends perpendicularly upwards from the base.
 3. An inhaler as claimedin claim 2, wherein, in the removed position of the separating element,the attached foil portion at least partly defines a flow path for themedicament entrained from the cavity.
 4. The inhaler as claimed in claim2, wherein the separating element comprises a returned position in whichthe separating element with the attached foil portion is moved back tocover its associated cavity.
 5. (canceled)
 6. The inhaler as claimedclaim 2, wherein the attachment force between each separating elementand the respective associated foil portion is larger than the attachmentforce between the base and the foil portion, whereby movement of theseparating element away from its associated cavity causes the associatedfoil portion to become separated from the base.
 7. The inhaler asclaimed in claim 6, wherein the contact surface between a separatingelement and its associated foil portion is larger than the contactsurface between that foil portion and the base.
 8. The inhaler asclaimed in claim 6, wherein each foil portion comprises a first coatinglayer to which the base is attached and a second coating layer to whichthe separating element is attached, wherein the tensile strength of thesecond coating layer is larger than the tensile strength of the firstcoating layer.
 9. The inhaler as claimed in claim 6, wherein thestiffness of each separating element is substantially larger than thestiffness of the associated foil portion, wherein the separating elementenables the foil portion to perform a rigid body motion.
 10. The inhaleras claimed in claim 2, wherein said base is shaped as a circular diskand wherein the cavities are provided consecutively in a circulararrangement around the disk. 11-14. (canceled)
 15. An inhaler,comprising a base having a plurality of medicament-containing sealedcavities which are consecutively movable to a dispensing position of theinhaler, foil portions which on one side are attached to the base forsealing the medicament within respective associated cavities and whichon an opposite side are attached to a plurality of separating elements,each separating element being associated with a respective cavity forseparating a foil portion from that cavity, and an actuator adapted toprovide an impact on the separating element associated with the cavitycurrently located in the dispensing position, thereby moving thatseparating element to a removed position in which the separating elementis moved-away from the cavity so that the sealing foil portion isseparated from the cavity which is thereby uncovered so that medicamentcontained therein is enabled to become entrained in a fluid flow,wherein, in the removed position of the separating element, the attachedfoil portion at least partly defines a flow path for the medicamententrained from the cavity, and wherein each foil portion comprises afirst coating layer to which the base is attached and a second coatinglayer to which the separating element is attached, wherein the tensilestrength of the second coating layer is larger than the tensile strengthof the first coating layer.
 16. An inhaler, comprising a base having aplurality of medicament-containing sealed cavities which areconsecutively movable to a dispensing position of the inhaler, foilportions which on one side are attached to the base for sealing themedicament within respective associated cavities and which on anopposite side are attached to a plurality of separating elements, eachseparating element being associated with a respective cavity forseparating a foil portion from that cavity, and an actuator adapted toprovide an impact on the separating element associated with the cavitycurrently located in the dispensing position, thereby moving thatseparating element to a removed position in which the separating elementis moved-away from the cavity so that the sealing foil portion isseparated from the cavity which is thereby uncovered so that medicamentcontained therein is enabled to become entrained in a fluid flow,wherein the cavities are adapted to be indexed relative to the actuator,and wherein each foil portion comprises a first coating layer to whichthe base is attached and a second coating layer to which the separatingelement is attached, wherein the tensile strength of the second coatinglayer is larger than the tensile strength of the first coating layer.17. An inhaler as claimed in claim 16, wherein, in the removed positionof the separating element, the attached foil portion at least partlydefines a flow path for the medicament entrained from the cavity. 18.The inhaler as claimed in claim 16, wherein the separating elementcomprises a returned position in which the separating element with theattached foil portion is moved back to cover its associated cavity. 19.The inhaler as claimed in claim 16, wherein a partition wall is providedbetween each pair of neighbouring separating elements, and extendsperpendicularly upwards from the base.
 20. The inhaler as claimed inclaim 16, wherein the attachment force between each separating elementand the respective associated foil portion is larger than the attachmentforce between the base and the foil portion, whereby movement of theseparating element away from its associated cavity causes the associatedfoil portion to become separated from the base.
 21. The inhaler asclaimed in claim 20, wherein the contact surface between a separatingelement and its associated foil portion is larger than the contactsurface between that foil portion and the base.
 22. The inhaler asclaimed in claim 20, wherein the stiffness of each separating element issubstantially larger than the stiffness of the associated foil portion,wherein the separating element enables the foil portion to perform arigid body motion.
 23. The inhaler as claimed in claim 22, wherein saidbase is shaped as a circular disk and wherein the cavities are providedconsecutively in a circular arrangement around the disk.